Mancini 2003.

Methods	Study design: randomised controlled trial Study grouping: parallel group Total number: 70 participants (50 in balneotherapy group and 20 control group) Start date: no details given Duration of participation: 6 months End date: no details given Method of randomisation: asymmetrically on blocks of 7 participants, 5 to enter group A and 2 group B Blinding: participants – no; treating professional – no; outcome assessors – yes Power calculation: no details given Losses to follow‐up: 5 (all in control group: 4 refused to come back and 1 had an episode of deep vein thrombosis) Unit of allocation: participant Source of funding: no details given
Participants	Setting: outpatients (secondary care) Country: Italy Gender: 18 men and 52 women Age (range): 19–78 years Inclusion criteria: aged 18–85 years, both sexes and informed consent, people with primary monolateral or bilateral varices of the reticular or truncular type, symptomatic, with or without oedema, skin changes, or healed ulcer, variously localised in the superficial veins, with or without perforating veins or reflux. Exclusion criteria: people with active venous ulcer, deep vein thrombosis within the previous 12 months or superficial phlebitis within the previous 6 months, or recurrent forms, vein surgery or sclerotherapy within the previous 6 or respectively 3 months, any general condition contraindicating spa treatments.
Interventions	Technique: included balneokinesis (passive and active balneotherapy), consisting of assisted walking in 2 basins containing thermal water at 27 °C (passive) and 31 °C (active). Besides walking, the participants were asked to perform lower limb exercises in water assisted by a physiotherapist. The whole balneokinetic exercise lasted 30 minutes. Treatment was performed with sulphurous salso‐bromojodinated carbon dioxide‐rich water from local springs (sulphidimetric grade 7, 25 mg/L) Balneotherapy group: balneotherapy for 12 days and elastic compression Control group: elastic compression alone Duration of follow‐up: 6 months
Outcomes	Outcomes relevant for this review (collected) Quality of life (SF‐36 form, in an Italian translation validated for use in Italy. The questionnaire was administered at entry and after 6 months) Reported outcomes A score as suggested in the mentioned CEAP table (0 = absent; 1 = moderate; 2 = severe) was assigned to these symptoms on the basis of the participant's complaints. VFT measured by light reflex plethysmography
Identification	Authors name: Sergio Coccheri Institution: Cardiovascular Department, Chair and Division of Angiology, University Hospital St Orsola email: coccheri@med.unibo.it
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about sequence generation.
Allocation concealment (selection bias)	Low risk	Allocation performed asymmetrically on blocks of 7 participants, 5 to enter group A and 2 to enter group B.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and spa physician not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details given.
Incomplete outcome data (attrition bias) All outcomes	Low risk	5 participants (all in the control group) lost to follow‐up.
Selective reporting (reporting bias)	Low risk	All outcomes reported on.
Other bias	Unclear risk	No evidence of other bias.